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FDA Accepts sBLA for Pembrolizumab in Combination With Chemotherapy as First-Line Treatment for Metastatic Squamous NSCLC

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The U.S. Food and Drug Administration (FDA) has accepted for review a supplemental biologics license application (sBLA) for pembrolizumab (Keytruda) in combination with carboplatin/paclitaxel or nab-paclitaxel (Abraxane) as a first-line treatment for metastatic squamous non–small cell lung cancer (NSCLC), regardless of programmed cell death ligand 1 (PD-L1) expression. This sBLA, which is seeking accelerated approval for this new indication, is based on data from the phase III KEYNOTE-407 trial, which was recently presented at the 2018 ASCO Annual Meeting. The FDA has granted Priority Review to this sBLA and set a Prescription Drug User Fee Act, or target action date, of October 30, 2018.

“Pembrolizumab has already been established as an important treatment option for non–small cell lung cancer in the first-line setting, and with our broad development program in lung cancer, we are committed to improving survival for as many patients as we can,” said Roy Baynes, MD, PhD, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, Merck Research Laboratories. “We are pleased that our application for squamous cell carcinoma—a historically challenging-to-treat disease—is under Priority Review with the FDA.”

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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